Early engagement and regulatory considerations for biotech

What companies must consider when developing an asset and the importance of regulatory strategy


Gain insight into the common questions small and emerging biotech companies face, and the importance of early engagement and regulatory affairs when developing an asset and considering a drug development partner.

Emerging biotech companies continue to be a productive and innovative force across the biopharma development market. Demand for orphan drugs and personalised medicines has driven considerable growth in the biopharma industry and an influx of these emerging and innovative biotech companies. Despite robust funding and government initiatives, these companies are typically very lean on internal resources and sometimes even “virtual” by design – thus lacking the internal development operations infrastructure required to successfully develop and take an asset to market.

This whitepaper details:

  • How to navigate the complexities of drug development
  • Considerations that can help lead an emerging company forward and achieve optimal success in their partnerships
  • Why small and emerging biotech companies should engage a regulatory strategist in all aspects of product development